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E. Gabrielsen Hjelle et al.
lity of a response shift into the assessment. A response
shift is a change in the meaning of one’s self-evaluation
due to changes in the respondent’s internal standards
of measurement and values or a redefinition of the
construct by the respondent (38). A response shift may
lead to a reconsideration of the current life and affect
the outcome measurement scores. This outcome could
occur in both groups regardless of adding an interven-
tion and may result in underestimating the treatment
effect of psychosocial interventions (38).
The strengths of the study were the thorough de-
velopment, feasibility and customization of the inter-
vention, which were conducted as recommended by
the UK MRC guidance for developing and evaluating
complex interventions (13).
In addition, the study was conducted per the rigorous
recommendations in the CONSORT statement (39).
The intervention fidelity was high and the study was
conducted according to protocol.
All personnel involved in the data collection and
intervention delivery, underwent a 3-day training
programme, individual guidance according to need
by members of the research team and participation in
group sessions throughout the study.
However, the study had some limitations. We cannot
be sure that the training and follow-up of the interven-
tion personnel were sufficient for all of them.
Although the participants represented the largest
group of stroke patients admitted to hospitals in Nor-
way, patients with the most severe stroke or aphasia
were difficult to include due to early enrolment and
difficulties in obtaining informed consent.
The 2 most common reasons for declining to partici-
pate, were that they did not feel the intervention suited
them or that they had too much going on to commit to
participation, but detailed information on the reasons
for non-participation were limited due to strict ethics
guidelines limiting questions regarding decline.
If a standardized test was not applied in the evalu-
ation of cognitive function (e.g. due to aphasia), the
recruiting personnel reported cognitive challenges as
“mild”, “moderate” or “severe”, based on information
from the assessments made by the multidisciplinary
team. This procedure did not provide reliable informa-
tion that was applicable to the analysis.
Unfortunately, we do not have a sufficient number
of participants to perform subgroup analyses for po-
tentially vulnerable groups, such as those experiencing
cognitive challenges, aphasia or lacking social support.
In addition, we questioned whether the control group
functioned as intended, because participants in both the
intervention and control groups had substantial follow-
up time as part of their usual care. The control group
also received personal home visits for data collection,
which they may have interpreted as an intervention,
www.medicaljournals.se/jrm
which thus may have impacted their psychosocial
well-being (More details from the control group expe-
riences will be reported as part of the study´s process
evalution) . The participation may also have increased
the awareness of stroke-related changes and facilitated
reflection on psychosocial well-being, changes and
symptoms that secondarily affected the outcome.
In conclusion, psychosocial well-being, as measured
by the GHQ-28, improved significantly during the first
6 months after stroke in both the intervention and con-
trol groups. The results at 6 months indicated that par-
ticipating in a dialogue-based intervention during the
first 6 months post-stroke in addition to usual care did
not affect psychosocial well-being. Further research is
needed to investigate which factors promote psychoso-
cial well-being after stroke, particularly among patients
at high risk of experiencing psychosocial problems.
ACKNOWLEDGEMENTS
The authors thank all the patients who participated in the
study. We acknowledge all participating centres of the RCT for
granting access to participants and especially the recruitment
personnel for their efforts in enrolling participants into the trial.
We thank the data collectors for their extensive contribution to
the complete data collection and the intervention personnel for
conducting a remarkable number of interventions.
Clinical Trial Registration. URL: https://clinicaltrials.gov.
NCT02338869; registered 10/04/2014.
Funding. The research leading to these results received funding
from the European Union Seventh Framework Programme
(FP7-PEOPLE-2013-COFUND) under grant agreement no.
609020 - Scientia Fellows (LKB), the South-Eastern Norway
Regional Health Authority (Project number 2013086) (US,
LKB) and the Extra Foundation (2015/FO13753) (EGH).
The authors have no conflicts of interest to declare.
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